EPA formaldehyde findings called into question by independent review

WASHINGTON -- The EPA's draft assessment of the potential health effects of formaldehyde in some cases goes beyond the available evidence and "needs substantial revision," according to a report issued today by the National Research Council.

Susan Poag / The Times-PicayuneFEMA worker Allison Davis posts a notice on a trailer in Myrtle Grove in July 2007 as part of a statewide effort to inform residents of FEMA-provided housing units about formaldehyde in the trailers and where they can call for additional information.

Elevated levels of formaldehyde in FEMA trailers were linked to a variety of respiratory ailments suffered by people who lived in the trailers after Hurricanes Katrina and Rita.

The NRC critique -- requested by EPA under pressure from Sen. David Vitter, R-La. -- concludes that EPA's analysis supports its conclusion that formaldehyde can irritate the eyes, nose and throat, create lesions in the respiratory tract and, in high concentrations, lead to genetic mutations. It also found that EPA demonstrated sufficient evidence that exposure to formaldehyde can cause cancers of the nose, nasal cavity and upper throat.

But the report asserts that EPA failed to support its conclusion that formaldehyde causes other cancers of the respiratory tract or leukemia.

The NRC report also found that the EPA overstated the evidence in concluding that formaldehyde damages the nervous system, and in concluding that there is a "convincing" relationship between exposure to formaldehyde and reproductive problems, including infertility in women.

"I'm extremely glad I fought so hard for this review by the National Academy of Sciences, which really is the gold standard in terms of scientific assessment," Vitter said. "It confirms what I feared -- serious shortcomings and bias at the EPA. Louisiana citizens should be able to count on EPA conclusions and advice. This study shows that we can't."

The EPA issued a short statement in response to the release of the report: "EPA conducts peer review to assure only the highest quality science is used as the basis of our actions. We will carefully and expeditiously review the report, as we do with all peer review reports, and examine how best to respond to its recommendations. Strong science depends on peer review and the robust discussions among scientists represents a strong scientific process."

Vitter had forced EPA to seek the review by the NRC, a part of the National Academy of Sciences, by placing a hold in 2009 on the appointment of Paul Anastas to be the EPA's assistant administrator in charge of its Office of Research and Development until EPA Administrator Lisa Jackson relented and asked for the NAS review In its 1,043-page draft assessment, EPA had concluded that formaldehyde is carcinogenic when inhaled by humans, a finding that, once finalized, would lead to an update EPA's risk assessment of formaldehyde and more stringent regulation of the ubiquitous chemical.

The new report by the NRC could further slow a process already more than a decade in the making.

Becky Gillette, Formaldehyde Campaign Director for the Sierra Club, reacted with dismay to the NRC report, which she views as part of a stalling maneuver by industry and its allies in Congress.

"David Vitter has delivered for the formaldehyde industry that filled his campaign coffers," Gillette said. "If a senator from a state that manufacturers trailers had done this, it would be one thing. But it is particularly ironic that this came from a senator from Louisiana, where thousands of people lost their homes in Hurricanes Katrina and Rita and then had insult added to injury by being placed in toxic FEMA trailers."

"I'm thinking of the people in FEMA trailers I worked with who died, and the parents who lost babies or had babies born sick," said Gillette.

"If one good thing should have come out of this horrible public health nightmare, it should have been proper regulation of formaldehyde. But this NAS report is more business as usual under a government that is increasingly not a democracy, but owned by wealthy business interests," Gillette said. "I still get a couple calls a week from people in trailers -- 103,000 former FEMA trailers were dumped on the market by the government - who are sick, scared and angry that the government hasn't protected them. Many don't have a choice of other places to live."

But the American Chemistry Council, a trade organization, applauded the NRC's work.

"We appreciate the thorough and comprehensive nature of the NAS report. The recommendations are consistent with the World Health Organization's guidelines on formaldehyde," said Senior Director Ann Mason. "We call upon EPA to adopt the NAS findings when revising the IRIS Risk Assessment for formaldehyde."

Masson said that the draft for EPA"s "Integrated Risk Information System," as written, could have led to setting acceptable levels of exposure to the naturally occurring substance at unrealistically low levels.

"The levels of formaldehyde at which most people are exposed are not high enough to cause adverse health effects, according to the large body of research available," Mason said. "In its draft assessment, EPA proposes setting a cancer risk value significantly below the levels that occur naturally in the environment. For example, WHO reports people produce formaldehyde in their bodies and exhale it in the range of less than 0.8 to 8 parts per billion. EPA's proposed cancer risk value of 0.008 parts per billion would suggest that human breath poses an unacceptable risk of cancer; yet, experience and science tell us that couldn't possibly be the case."

The NRC report notes that "formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily." It is used in a variety of products, especially building materials, is emitted from power plants, cars, gas and wood stoves and cigarettes, is found in some foods, and is naturally present in the human body.

The NRC found the draft assessment to be overlong and often unclear and unfocused and that it suffered from "recurring methodological problems," similar, it said, to those other NRC committees found in other EPA assessments of other chemicals.

The NRC was organized by the NAS, which is a private, non-profit society of scholars. The committee to review EPA's draft assessment consisted of 15 members, led by Jonathan Samet, an expert on the human health effects of air pollutants at the University of Southern California, who chaired the panel, and its vice chair, Andrew Olshan, who chairs the Department of Epidemiology at the University of North Carolina School of Public Health.

The committee's mandate was not to perform its own assessment of the risk of formaldehyde, but to examine the EPA assessment and key literature to see whether the agency's conclusions were well-supported.